U.S. patent number 7,231,015 [Application Number 10/276,060] was granted by the patent office on 2007-06-12 for device for radiation therapy.
Invention is credited to Muradin Abubekirovich Kumakhov.
United States Patent |
7,231,015 |
Kumakhov |
June 12, 2007 |
Device for radiation therapy
Abstract
Device, related to the means for radiation therapy of malignant
and benign neoplasms and certain other diseases, comprise hollow
probe 5, source 1 of neutral particle radiation in the form of
X-ray or gamma quanta or neutrons, and means of shaping the
particle beam of said radiation oriented by the longitudinal axis
of the probe. Means of shaping the particle beam is executed in the
form of collimator or lens 18 comprising aggregate of curved
channels for radiation transmission with a total internal
reflection. Said means may be located inside of the probe 5. On
using the device, probe 5 is introduced into the body of patient
11, with its distal end 7 approaching pathological locus 13 or
inserted directly into it. For exposure of pathological locus, use
is made of radiation of the neutral particles source directly or
secondary radiation excited in the target placed in the distal end
of the probe or radiation dissipated with this target. Design of
the device requires no evacuation of the probe and use of high
voltage in the latter, is easily transformed by the probe
replacement, in particular, to change its size, to change energy
and directional pattern of radiation affecting the pathological
locus. Making of the probe removable simplifies its
sterilization.
Inventors: |
Kumakhov; Muradin Abubekirovich
(Moscow, RU) |
Family
ID: |
20129648 |
Appl.
No.: |
10/276,060 |
Filed: |
September 19, 2001 |
PCT
Filed: |
September 19, 2001 |
PCT No.: |
PCT/RU01/00384 |
371(c)(1),(2),(4) Date: |
November 13, 2002 |
PCT
Pub. No.: |
WO03/024527 |
PCT
Pub. Date: |
March 27, 2003 |
Prior Publication Data
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|
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Document
Identifier |
Publication Date |
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US 20040013230 A1 |
Jan 22, 2004 |
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Current U.S.
Class: |
378/65;
378/147 |
Current CPC
Class: |
A61N
5/1001 (20130101); G21K 1/06 (20130101); A61N
5/1014 (20130101); G21K 2201/064 (20130101); G21K
2201/067 (20130101); A61N 2005/1091 (20130101); A61N
2005/1095 (20130101) |
Current International
Class: |
A61N
5/10 (20060101) |
Field of
Search: |
;378/64-65,147,149,84
;600/427 ;604/20-21 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2120787 |
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Oct 1998 |
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RU |
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01/29845 |
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May 2000 |
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WO |
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02/02188 |
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Jul 2000 |
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WO |
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Other References
Stavitskij, "Aspects of Clinical Dosimetry," Moscow, "MNPI," 2000,
pp. 1-9 and 386-388 (in Russian); and extract of contents (in
English). cited by other .
E.S. Kiseleva, "Radiation Therapy of Malignant Tumors. Guide for
Physicians," Moscow, "Meditsina" Publishing Houe, 1996, pp. 1-79
and 460 (in Russian); and extract of contents (in English). cited
by other .
Larsson, Crawford, and Weinreich, Advances in Neutron Capture
Therapy vol. II, Chemistry and Biology; Elsevier 1997, pp. iv-xv.
cited by other .
Kumakhov, "Optics of Beams," Institute for Roentgen Optical
Systems, Moscow 1993, pp. 1-17. cited by other.
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Primary Examiner: Song; Hoon
Attorney, Agent or Firm: McDermott Will & Emery LLP
Claims
The invention claimed is:
1. A device for performing radiation therapy comprising: a
sharpened hollow probe having dimensions of a puncture needle for
biopsy and insertable into a patient's body, the hollow probe
having a proximal end portion and a distal end portion for
approaching or being introduced directly into a pathological locus,
and a beam shaping unit for shaping a beam of radiation particles
generated by a source of x-rays, gamma radiation, or neutrons, the
beam shaping unit is made in a form of a lens including multiple
curved radiation transmission channels for forming a quasi-parallel
or focused beam directed along a longitudinal axis of the hollow
probe, wherein the lens is at least partially arranged in the
hollow probe, and the proximal end portion of the hollow probe is
non-transparent for the radiation particles.
2. The device of claim 1, wherein the hollow needle is removable
from the device.
3. The device of claim 1, wherein a secondary target arranged in
the hollow probe, adjacent to the distal end portion for scattering
radiation incident at the secondary target or for exciting
secondary radiation.
4. A device for performing radiation therapy comprising: a hollow
needle insertable into a patient's body, the hollow needle having a
proximal end portion and a distal end portion for approaching or
being introduced directly into a pathological locus; a beam shaping
unit for shaping a beam of radiation particles generated by a
source of x-rays, gamma radiation, or neutrons, the beam shaping
unit including a collimator or a lens for directing the beam along
a longitudinal axis of the hollow needle, the beam shaping unit
being at least partially arranged in the hollow needle, the
proximal end portion of the hollow needle being non-transparent for
the radiation particles; and a secondary target arranged in the
hollow needle, adjacent to the distal end portion for scattering
radiation incident at the secondary target or for exciting
secondary radiation.
5. The device according to claim 4, wherein the distal end portion
is removable from the hollow needle.
6. The device according to claim 5, wherein the secondary target is
replaceable.
7. A device for performing radiation therapy comprising: a hollow
needle for introduction into a patient's body, the hollow needle
having a proximal end portion and a distal end portion for
approaching or being introduced directly into a pathological locus,
a beam shaping unit for shaping a beam of radiation particles
generated by a source of x-rays, gamma radiation, or neutrons, the
beam shaping unit including a collimator or a lens for directing
the beam along a longitudinal axis of the hollow needle, the beam
shaping unit being at least partially arranged in the hollow
needle, and a secondary target arranged in the hollow needle,
adjacent to the distal end portion for scattering radiation
incident at the secondary target or for exciting secondary
radiation, wherein the proximal end portion of the hollow needle
being non-transparent for the radiation particles.
8. The device according to claim 7, wherein the distal end portion
is removable from the hollow needle.
9. The device according to claim 8, wherein the secondary target is
replaceable.
10. The device of claim 7, wherein the hollow needle has dimensions
of a puncture needle for biopsy.
11. The device of claim 7, wherein the hollow needle is removable
from the device.
Description
FIELD OF THE INVENTION
The present invention relates to means for radiation therapy of
malignant and benign neoplasms and certain other diseases.
BACKGROUND OF THE INVENTION
At present, treatment with ionizing radiation is widely used not
only in the therapy of malignant neoplasms, but benign tumors and a
series of inflammatory and other diseases of nonneoplastic nature
as well (Aspects of Clinical Dosimetry, Ed. R. V. Stavitskij,
Moscow, "MNPI", 2000 [1] (in Russian)).
Devices are known for radiation therapy which comprise X-ray
source, oriented for the purpose of directing radiation created
with it to the pathological locus area. In order to minimize
irradiation of healthy tissues surrounding pathological locus, such
devices may comprise several X-ray sources. The irradiation created
with them is directed to the pathological locus area from different
directions (Radiation Therapy of Malignant Tumors. Guide for
Physicians. Ed. Prof. E. S.Kiseleva, Moscow, "Meditsina" Publishing
House, 1996 [2] (in Russian)).
Device is also known for radiation therapy comprising several X-ray
sources whose radiation, being aimed to the area of pathological
locus from different directions, is focused with X-ray lenses
(international application PCT/RU 00/00273, WO 01/29845A16 26 Apr.
2001 [3]). Due to the said focusing, radiation from each of the
lenses on passing through the healthy tissues has in them lower
concentration than in the pathological locus.
More radical way to decrease irradiation of healthy tissues
surrounding the pathological locus comprise its irradiation not
from outside, but from the inside.
Such a way is realized, in particular, by implantation of a capsule
with radioactive material directly into the pathological locus [2].
This method has drawbacks of the necessity of surgical intervention
and associated with it difficulty in the control of irradiation
duration.
The most close to the device proposed is a known device disclosed
in U.S. Pat. No. 5,153,900 [4] (Russian analogue patent No.
2,155,413) and in number of other patents belonging to
Photoelectron Corporation. This known device comprise a probe
device for introduction directly into the pathological locus or for
approaching it. Probe device in said device is a part of X-ray
tube. Its anode is situated at the distal end of probe device.
Proximal end of probe device adjoins the outlet of means for
electronic beam formation, which is directed along the longitudinal
axis of the probe device towards anode.
Within the probe of this device vacuum should be maintained (as
within any X-ray tube). This fact in combination with the necessity
of high voltage supply to the anode situated at distal end of a
thin lengthy probe and the necessity to control position of
electronic beam make for design complexity of the device. At that,
radiation energy is determined substantially by anode material.
Impossibility of anode replacement in the evacuated probe results
in necessity of having separate device for each radiation energy
desired. The same is true for changing spatial radiation pattern by
matching the radiotransparency ratio of different portions of the
distal probe end. Operation of the device utilizing electronic beam
is influenced with external magnetic fields, thus necessitating to
make arrangements on corresponding shielding. Realization of the
probe as a part of X-ray tube complicates substantially its
sterilization. Overcoming of this drawback by providing the probe
with removable sheath increases its diameter and is associated with
a rise in traumatism on utilization of the device. Therefore,
primary field of utilization of said device is treatment of tumors
of hollow organs requiring no puncturing and situated in immediate
communication with outer environment, such as urinary bladder,
rectum, etc. Besides, said device, comprising probe as a
constituent part of X-ray tube, is applicable for treatment with
X-ray radiation only.
DISCLOSURE OF THE INVENTION
It is an object of the present invention to provide for technical
result consisting in: possibility of application for therapy
utilizing not only X-ray, but other kinds of radiation as a flux of
neutral particles as well; design simplification and costs
reduction due to avoidance of utilization of vacuum and high
voltage, and elimination of control means of electronic beam and
magnetic shielding; easy transformation by the way of probe
replacement, in particular, for changes of its size, and changes in
energy and directional radiation pattern acting on the pathological
locus; simplicity of the probe sterilization, and possibility of
utilization of interchangeable or disposable probes; possibility of
the probe disconnection from the rest of device, leaving it in
patient's body, and utilization of the device at this time with
other probe.
In order to achieve mentioned kinds of technical result the
proposed device for radiation therapy, similar to the known one
mentioned above, comprises probe device for introduction into
patient's body and approaching of its distal end to pathological
locus or immediate introduction into it, irradiation source, and
means of formation of particle beam of said radiation, oriented
along the longitudinal axis of said probe.
Distinction of the proposed device from the known one lies in the
fact of said radiation source being the source of neutral particles
in the form of X-ray ones or gamma quanta or neutrons. At that,
means of formation of particle beam of said radiation, oriented
along the longitudinal axis of the probe, is executed as collimator
or lens, comprising aggregate of curved channels for radiation
transmittance with a total internal reflection.
With such design of the proposed device, as distinct from the known
one, pathological locus is acted upon immediately with radiation of
the neutral particles source used, coming through thin probe to the
pathological locus or into it. Said radiation, notwithstanding the
fact of being created with a source situated outside of body of the
ill person, doesn't affect healthy tissues on the way to the
pathological locus. This is achieved due to its propagation inside
of the probe.
Due to the absence of vacuum and high electric voltage in the probe
it may be executed as a removable one, thus making easy its
sterilization. The device may be provided with a set of probes
having different size.
The probe, except for its distal end or its separate portions, may
be executed non-transparent for the particles emitted with
radiation source and intended for action on the pathological
locus.
Means of the particle beam formation oriented along the
longitudinal axis of the probe may be situated both outside of the
probe--between it and the source of high energy neutral
particles--and partially or wholly inside of the probe.
In the case of the means of particle beam formation oriented along
the longitudinal axis of the probe situated wholly inside of the
probe and being a collimator, the latter may have single
channel.
In the case of the means of particle beam formation oriented along
the longitudinal axis of the probe being executed in the form of a
lens comprising aggregate of curved channels for radiation
transmittance with a total internal reflection, such a lens may be,
in particular, a focusing lens with a focus situated outside of the
probe on continuation of its longitudinal axis. In this case, focus
is located within patient's body near to or inside of the
pathological locus.
Said lens may be also a lens for formation of quasi-parallel beam
passing through the probe and going out from its distal end.
In the case of radiation source being an X-ray source, the latter
may be executed with a sectioned anode for on-line change in
particle energy.
A secondary target may be located at the distal end of the probe.
In this case, source radiation dissipated by secondary target or
excited radiation of the secondary target material is used for
radiation exposure.
In the case of the means of particle beam formation oriented along
the longitudinal axis of the probe being made in the form of lens
comprising aggregate of curved channels for radiation transmittance
with a total internal reflection, such a lens may be, in
particular, a focusing lens with a focus located on the secondary
target.
In order to change characteristics of radiation dissipated and
excited in the secondary target material, distal end of the probe
may be made split with a possibility of replacement of the
secondary target mounted in it. At that, secondary target mounted
in the distal end of the probe is one of the several in the device
set supplied, for example, made of different metals.
For the on-line change of desired directional radiation pattern
emanating from the distal end of the probe and acting on the
pathological locus, distal end of the probe may be made removable.
In this case, probe has one of the several distal ends from the
device set, executed with different transparency ratios of portions
of the distal end surface of the probe for radiation dissipated and
excited in the secondary target material.
In order to ensure coagulation of wound channel arising in the
course of puncture with a probe after completion of treatment
procedure, the latter may be made electrically conductive and
having on the outside, except for the most remote portion of the
distal end, insulating coating. In this case, the probe should have
possibility of being connected to electrocoagulator.
BRIEF DESCRIPTION OF DRAWINGS
The inventions proposed are illustrated with drawings, in which are
depicted:
FIG. 1 - schematic representation of the device as a whole together
with several probes coming in the set;
FIG. 2 - utilization of the device for irradiation of extended
tumor;
FIG. 3 - utilization of the device with lens positioned outside of
the probe for irradiation of a small tumor;
FIG. 4 - lens positioning partially inside of the probe;
FIG. 5 - device with a lens effecting collimation and focusing of
the source radiation;
FIG. 6 - the probe serving simultaneously as a collimator with a
single channel;
FIG. 7 - utilization of the device in combination with
coagulator;
FIG. 8 - distal end of the probe with a secondary target installed
in it, which is being irradiated with a quasi-parallel beam;
FIG. 9 - distal end of the probe with a secondary target installed
in it, which is being irradiated with a focused beam;
FIG. 10 - a probe with several removable distal ends.
THE EMBODIMENTS OF THE INVENTION
The device proposed comprises (FIG. 1, A) a source of neutral
particles (X-ray or gamma quanta or neutrons), protective shield 2
with a diaphragm 3 situated in front of the outlet aperture of
source 1, means 4 of formation of particle beam oriented along
longitudinal axis of the probe 5. The latter has tapered distal end
7. Proximal end 6 of the probe 5 may be executed in such a way as
to ensure possibility of the probe removal (for example, for
sterilization and replacement with another one). The set of the
device may include several probes, for example, of different length
(FIGS. 1, B and C).
The probe may be similar in form and dimensions to a puncture
needle for biopsy.
In the course of device usage the probe is introduced, depending on
the localization of pathological locus, into one of the natural
passages of patient's body or perform puncturing similar to biopsy
procedure.
FIG. 2 shows position of the probe 5 in the body of patient 11.
Quasi-parallel beam 10 of radiation comes to the proximal end 6 of
the probe. This beam is transmitted through the inner channel of
the probe 5 and goes out through radiolucent distal end 7. The
latter in the case shown in FIG. 2 is situated in the immediate
proximity of extended tumor 12. The direction of the probe
introduction is selected so that the radiation outgoing from the
distal end 7 would enter the tumor 12 and propagate in the
direction of a larger dimension. The radiation penetrating into the
tumor affects directly tissues in median part of the tumor situated
in its way. Tumor tissues surrounding the median ones are affected
with the secondary radiation excited in the median tissues. Since
radiation emerging from the distal end of the probe has practically
no effect on the healthy tissues, the intensity of primary
radiation of the source may be selected in such a way as to ensure
that the intensity of secondary radiation of the median tissues
reaching tumor periphery is on the level with that minimally
sufficient for damaging peripheral tissues. In this case, secondary
radiation reaching beyond tumor limits will not damage healthy
tissues, which surround it.
To affect neoplasms having small size, it is expedient to use a
focused beam outgoing from the distal end 7 of the probe 5. FIG. 3
shows embodiment of the device in which divergent radiation from
X-ray source having small aperture 14 is focused with a X-ray lens
15 and transmitted through a probe 5 introduced into the body of
patient to the center 16 of tumor 13. Similar to the above
considered case, peripheral tissues of the tumor 13 are irradiated
with excited secondary emission.
When using a source of neutrons as radiation source, use of the
device proposed may be combined with a method of boron capturing
therapy which ensures boron concentration in the tumor 5 (Advances
in Neutron Capture Therapy. Editors: B. Larsson, J. Crawford, R.
Weinrech. Elsevier, 1997 [5]).
Up-to-date technology of X-ray manufacturing allows to obtain
single piece lenses of a small size (see, for example, M.
A.Kumakhov. A history of the X-Ray and neutron capillary optics.
Optic of beams, p.p. 3-17, Moscow, 1993 [6]), acceptable for
placement partially or totally inside of the probe. Corresponding
embodiments of the device are shown in FIG. 4 and FIG. 5.
In FIG. 4, focusing lens 15 is situated inside of the probe 5, with
divergent radiation from the source having small aperture 14 coming
in at the input. Focusing is accomplished in the point 16 situated
outside of the radiolucent distal end 7 of the probe 5 on the
continuation of its longitudinal axis.
In FIG. 5, lens 18 is forming a beam focused in the point 16
situated inside of the pathological locus 13, out of radiation of
the source 1 having relatively large outlet aperture 17. The upper
part of the lens 18 has parallel channels and plays a role of
collimator. In this part of the lens, quasi-parallel beam of the
particles forms, which id transmitted through its channels. After
that, similar to ordinary lens for quasi-parallel radiation
focusing, it is transformed into focused beam coming out of the
lower end of the lens 18. Protective shield 2 protects patient 11
against radiation of the source 1, scattering past the lens 18.
In all the cases considered the radiation used, though created by a
source located outside of the patient's body, doesn't affect
healthy tissues situated on the way to the pathological locus. This
is ensured due to the fact of healthy tissues being mechanically
isolated from the radiation beam path by the probe walls, as well
as to their shielding effect. For that, they are made radio-opaque
to the radiation used. Although oriented radiation beam directed
into the probe may not transverse walls of the probe, if being
shaped sufficiently accurately, this measure is an additional
guarantee of radiation being emitted only through portions of the
distal end of the probe intended for this purpose.
FIG. 6 demonstrates utilization of the device, in which shaping of
the close-to-parallel beam going out of the distal end 7 of the
probe 5 is effected by the probe itself. In the given case it
functions as a collimator having single channel formed by side
walls of the probe 5. With corresponding selection of the probe
length and distance between its proximal end 6 and outlet aperture
14 of the radiation source, radiation 20 emerging from the distal
end 7 has a small divergence angle and is close to parallel. Such
work of the device is equivalent to placing of the means of
quasi-parallel particle beam shaping inside of the probe.
In order to effect radiation treatment, it is possible to use
simultaneously several probes introduced into different portions of
a tumor.
In all the cases of utilization of X-ray source as a radiation
source, the latter may be executed with a divided anode for on-line
changes in the particles energy.
In order to ensure coagulation of wound channel arising in the
course of puncture with a probe after completion of treatment
procedure, the latter may be made electrically conductive and
having on the outside (see FIG. 7) an insulating coating 23, except
for the most remote portion 22 of the distal end. In this case, the
probe should have possibility of being connected to
electrocoagulator 24. On applying electric voltage from the
coagulator between the probe 5 and body of patient 11 in the course
of probe removal (arrow 25 in FIG. 7), "welding" of the wound
channel 26 takes place. It prevents spreading of tumor 13 cells
beyond the malignant locus (in this case, technique used is similar
to that described in the patent of Russian Federation No. 2120787
[7]).
A secondary target may be located in the distal end of the probe.
In this case, source radiation dissipated with a secondary target
or secondary radiation of a target is used for radiation
treatment.
FIG. 8 demonstrates a case of utilization of radiation 29 excited
in the secondary target material, which is brought out through
windows 28 transparent for this kind of radiation. Those latters
are situated in such a way as to form desired directional pattern
of emergent radiation. For example, in case of uniform distribution
of windows in a narrow strip over perimeter of the distal end 7,
radiation will be concentrated in a narrow spherical sector. By
changing depth of the probe introduction into the body of patient
(in particular, into the tumor), position of this sector may be
regulated for treatment of the selected part of the tumor. At that,
different treatment tactics may be realized. For example, the probe
may be displaced at variable speed or brought to stop for different
time periods in different locations, thus regulating the degree of
radiation exposure of different parts of the tumor, depending on
its size in the direction perpendicular to longitudinal axis of the
probe.
FIG. 9 demonstrates utilization of radiation dissipated by the
secondary target 27. Due to isotropic nature of the latter, by
making the distal end 7 of the probe radiolucent and target
locating close to the most remote part of the distal end, may be
obtained nearly omnidirectional radiation 29, including spreading
partially backwards (upward in FIG. 9). Introduction of the distal
end 7 directly into the tumor ensures irradiation of the largest
part of tumor tissues surrounding this end.
By utilizing secondary targets, the advantages of the device
proposed, which requires no evacuation of the probe, are realized
to a still greater extent. The replacement is made possible not
only of the probe as a whole, but also of its distal end 7, for
changeover from one type of the secondary target used to the
another one. FIG. 10 demonstrates realization of the probe 5 with a
removable distal end 7 and embodiments of the distal end with two
discussed above types of the secondary targets 27 and formation of
two kinds of directional patterns of secondary radiation 28, 29
(see FIGS. 10, A, B, and C, correspondingly).
In order to change characteristics of dissipated and secondary
radiation, distal end of the probe may be made split with a
possibility of replacement of the target mounted in it. At that,
secondary target mounted in the distal end of the probe is one of
the several in the device set supplied, for example, made of
different metals.
The probe 5 may have one of the several distal ends in the device
set executed with different transparency ratios of surface portions
of the distal end of the probe for radiation dissipated and excited
in the secondary target material.
INDUSTRIAL APPLICABILITY
The device proposed may be realized by utilization both typical
industrially manufactured radiation sources, such as X-ray tubes,
and sources of neutron radiation and radioisotopes.
SOURCES OF INFORMATION
1. Aspects of Clinical Dosimetry, Ed. R. V. Stavitskij, Moscow,
"MNPI", 2000 (in Russian).
2. Radiation Therapy of Malignant Tumors. Guide for Physicians. Ed.
Prof. E. S. Kiseleva, Moscow, "Meditsina" Publishing House, 1996
(in Russian).
3. M. A. Kumakhov. X-ray means of location determination and
radiation therapy of malignant neoplasms. International application
PCT/RU 00/00273, international publication WO 01/29845A1, 26 Apr.
2001.
4. Nomikos et al. Miniaturized low power X-ray source. U.S. Pat.
No. 5,153,900, publ. 06 Oct. 1992.
5. Advances in Neutron Capture Therapy. Editors: B. Larsson, J.
Crawford, and R. Weinrech. Elsevier, 1997.
6. M. A. Kumakhov. A history of the X-Ray and neutron capillary
optics. Optic of beams, p.p. 3-17, Moscow, 1993.
7. S. A. Astrakhantsev et al., Needle device for biopsy and
coagulation. Patent of Russian Federation No.2120787, publ. 27 Oct.
1998.
* * * * *